LIBI AIR VIRLAZA Dextromethorphan Cough Suppressant

Product NDC: 84314-000
11-digit product format: 843140000
Labeler code: 84314
Product ID: 84314-000_383c21e8-3753-16c8-e063-6394a90af170
Type: HUMAN OTC DRUG
Nonproprietary name: DEXTROMETHORPHAN
Dosage form: LIQUID
Route: TOPICAL
Labeler: Libi Pharm Ltd.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-01-07
Substance: DEXTROMETHORPHAN
Active strength: 10 mg/mL
Pharmacologic classes: Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN	10 mg/mL

Field, Values table
Field	Values
Unii	7355X3ROTS

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84314-000-30	LIBI AIR VIRLAZA Dextromethorphan Cough Suppressant	1 in 1 BOX	LIQUID	1		2
84314-000-30	LIBI AIR VIRLAZA Dextromethorphan Cough Suppressant	30 mL in 1 BOTTLE	LIQUID	30		2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84314-000	LIBI AIR VIRLAZA DEXTROMETHORPHAN COUGH SUPPRESSANT (DEXTROMETHORPHAN) LIQUID [LIBI PHARM LTD.]	1	Current NDC, 2 package rows	20240601_e4eea307-0a68-4f7d-b880-df231d3af724.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7355X3ROTS	DEXTROMETHORPHAN	125-71-3	DEXTROMETHORPHAN

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84314-000-30	84314000030	1 BOTTLE in 1 BOX (84314-000-30) / 30 mL in 1 BOTTLE	1 bottle	2024-01-07	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LIBI AIR VIRLAZA Dextromethorphan Cough Suppressant Liquid	Libi Pharm Ltd.	2025-06-23	HUMAN OTC DRUG LABEL	2